LIPID, CARE trials: Pravastatin improves post-AMI survival

Drug reduces risk of repeat heart attack, too

The world’s largest and longest-running heart trial, the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) study, shows heart attack survival rates are increased by almost a quarter with pravastatin (Bristol-Myers Squibb’s Pravachol).

Researchers compared the effects of the cholesterol-lowering medication (40 mg/day) with those of placebo over a period of six years in 9,000 patients ranging in age from 31 to 75.1 The study results demonstrate that the agent plays an important role in reducing death from a second heart attack and stroke in heart attack survivors. Pravastatin:

• reduced total deaths by 22%;

• reduced deaths from coronary heart disease by 24%;

• reduced the total number of heart attacks by 29%;

• reduced stroke by 19%.

Originally designed to be a seven-year study, LIPID was stopped early because of compelling evidence that patients treated with pravastatin derived significant benefits compared to patients taking placebo.

Study participants had a history of myocardial infarction or hospitalization for unstable angina and had cholesterol levels of 155-271 mg/dL. Both placebo and medication groups received advice on following a cholesterol-lowering diet. Death from coronary heart disease occurred in 8.3% of the patients in the placebo group and 6.4% of those in the pravastatin group. The incidence of all cardiovascular outcomes — AMI, death from coronary heart disease or nonfatal myocardial infarction, stroke, and coronary revascularization — was consistently lower among patients assigned to receive pravastatin.

Of patients who survive heart attacks, two-thirds typically suffer a second within seven to 13 months. In a related study, the cholesterol and recurrent events (CARE) trial, pravastatin was shown to reduce the risk of repeat cardiac events among women who have already had heart attacks.2

Researchers studied a group of nearly 600 postmenopausal women who had heart attacks three to 20 months earlier. All participants had cholesterol levels less than 240 mg/dL with LDL levels between 115 and 174. One group took pravastatin 40 mg/day for five years; the other group took a placebo. After one year, the risk of coronary events, including fatal and nonfatal heart attack and stroke for the medication group dropped by half.

Pravastatin is generally well-tolerated. Most common side effects are headaches, rash, and gastrointestinal disturbances.

Out of the recent 71st scientific session of the Dallas-based American Heart Association, come results of another trial underlining the benefits of cholesterol-reduction.

The AVERT (Atorvastatin Versus Revascular-ization Treatments) trial demonstrated that aggressive LDL reduction to levels below 100 mg/dL delays the first ischemic event and decreases need for revascularization.

AVERT enrolled 341 patients with stable coronary artery disease — all candidates for angioplasty — and randomized them to either atorvastatin (Parke Davis/Pfizer’s Lipitor) 80 mg/day or angioplasty. About 87% of patients on atorvastatin in the 18-month study were able to avoid revascularization during 18 months of follow up.

During follow up, patients on the lipid-lowering therapy had a 36% reduction in coronary events compared with angioplasty patients, with events occurring in 13% of atorvastatin patients and in 21% of angioplasty patients.

References

1. The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med 1998; 339:1,349-1,357.

2. Lewis SJ, Sacks FM, Mitchell JS, et al. Effect of pravastatin on cardiovascular events in women after myocardial infarction: The cholesterol and recurrent events (CARE) trial. JACC 1998; 32:140-146.


PORT IHD study available

You can order the Agency for Health Care Policy and Research’s final report on ischemic heart disease by calling the AHCPR Clearinghouse at (800) 358-9295. Outcome Assessment Program for Ischemic Heart Disease: Patient Outcomes Research Team (PORT) Report, a 72-page report, AHCPR publication No. 98-N003, is free while supplies last.